FDA.reportPublic FDA data

OASIS Tears

Product NDC
42126-6100
11-digit product format
421266100
Labeler code
42126
Product ID
42126-6100_b01eee93-b0f8-4523-8b85-3076dd02a272
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerin
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
OASIS Medical, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2007-11-01
Substance
GLYCERIN
Active strength
.22 g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Non-Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 6 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42126-6100-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage42126-6100-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42126-6100-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage42126-6100-10efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
OASIS Tears
Brand name suffix
Preservative-Free Lubricant Eye
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GLYCERIN.22 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PDC6A3C0OXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2702674Internal RxNorm lookup
2702676Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
d9d71b1d-82a6-42e7-9ef2-2d041daef936Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42126-6100-1OASIS TearsPreservative-Free Lubricant Eye10 in 1 POUCHSOLUTION/ DROPS104
42126-6100-1OASIS TearsPreservative-Free Lubricant Eye3 in 1 CARTONSOLUTION/ DROPS34
42126-6100-2OASIS TearsPreservative-Free Lubricant Eye5 in 1 POUCHSOLUTION/ DROPS54
42126-6100-2OASIS TearsPreservative-Free Lubricant Eye0.3 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.34

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
GlycerinACTIVE INGREDIENTPDC6A3C0OXOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
GlycerinACTIVE MOIETYPDC6A3C0OXOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
Hyaluronate SodiumINACTIVE INGREDIENTYSE9PPT4THOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
Sodium chlorideINACTIVE INGREDIENT451W47IQ8XOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
Sodium phosphate, dibasicINACTIVE INGREDIENTGR686LBA74OASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
Sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWOASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0ROASIS TEARS (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42126-6100OASIS TEARS PRESERVATIVE-FREE LUBRICANT EYE (GLYCERIN) SOLUTION/ DROPS [OASIS MEDICAL, INC.]4Current NDC, Legacy NDC, 4 package rows20250122_d9d71b1d-82a6-42e7-9ef2-2d041daef936.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 5 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRedicare LLC4d1e5089-22b0-7b3f-e063-6294a90a346a2026-03-16WarningsExact identifier
application number: M018
Leader Ultra Lubricating Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCardinal Healthd7f011a2-05ba-47c3-9519-d31602e105c72026-03-12WarningsExact identifier
application number: M018
Leader Restorative Formula Lubricant Eye DropsPROPYLENE GLYCOLCardinal Health87fef7e4-e5a8-4aad-94d2-f80f34826d972026-03-12WarningsExact identifier
application number: M018
Leader Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLCardinal Health5c5d6c13-9b51-48f0-8627-b60b0f707fd32026-03-12WarningsExact identifier
application number: M018
Focus PIHYPROMELLOSE EYE DROPS 0.7%COVALENT MEDICALe9b2afdd-049a-3987-e053-2a95a90a6cbb2026-03-09WarningsExact identifier
application number: M018
Rain Renewal Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRain Eye Drops, LLCbb451b22-c4f6-291d-e053-2a95a90a78012026-03-06WarningsExact identifier
application number: M018
Complete Eye Relief Sterile Lubricant Eye DropsHYDROXYETHYL CELLULOSESimilasan Corporation4c49493a-70f9-0fde-e063-6394a90aea202026-03-05WarningsExact identifier
application number: M018
Dry Eye Relief Sterile Lubricant Eye DropsGLYCERINSimilasan Corporation4c4cce1c-392e-354d-e063-6294a90a0ca32026-03-05WarningsExact identifier
application number: M018
Irritated Eye Relief Sterile Lubricant Eye DropsHYDROXYETHYL CELLULOSESimilasan Corporation4c4ddcdf-3037-c9cd-e063-6294a90a16d52026-03-05WarningsExact identifier
application number: M018
Refresh Optive Mega-3 PFCARBOXYMETHYLCELLULOSE SODIUM, GLYCERIN, POLYSORBATE 80Allergan, Inc.326cb5d6-c784-404f-9a13-6d69262dda6e2026-03-01WarningsExact identifier
application number: M018
Discount Drug Mart Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMDiscount Drug Mart4ba1b369-54e2-5224-e063-6394a90a47692026-02-25WarningsExact identifier
application number: M018
Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMKC Pharmaceuticals, Inc.4bafa882-50b7-e3e2-e063-6294a90a76e32026-02-25WarningsExact identifier
application number: M018
Viva Hydration BoostGLYCERINNomax Inc174193b2-65eb-b5fd-e063-6394a90a9cd02026-02-10WarningsExact identifier
application number: M018
Droptics Performance Eye DropsNAPHAZOLINE HYDROCHLORIDE, PROPYLENE GLYCOLDroptics LLC20fd6822-a7fd-4593-92bb-0a07260893e22026-02-09WarningsExact identifier
application number: M018
GoodSense Eye Drops Advanced Relief MoisturizerDEXTRAN, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLSportpharm LLC8d58dcbb-72a0-41f0-9eeb-613072a6d7ae2026-02-06WarningsExact identifier
application number: M018
MINIDROPSLUBRICANT EYE DROPSOptics Laboratory, Incc13c5f91-50df-471c-a7c9-1747a2ac12502026-02-03WarningsExact identifier
application number: M018
OptaseWHITE PETROLATUM, LANOLINScope Health Incc1991caa-51b9-13d1-e053-2995a90a12932026-01-31WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc376e0289-28e9-e87f-e063-6294a90a3b042026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc10c3e31d-779d-8ff6-e063-6294a90acd392026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc9e96976b-2990-79e0-e053-2995a90a0f292026-01-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2702674glycerin 0.22 % Ophthalmic SolutionPSNd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702676Oasis TEARS PF 0.22 % Ophthalmic SolutionPSNd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702676glycerin 2.2 MG/ML Ophthalmic Solution [Oasis Tears]SBDd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702674glycerin 2.2 MG/ML Ophthalmic SolutionSCDd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702674glycerin 0.22 % Ophthalmic SolutionSYd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702676Oasis Tears 2.2 MG/ML Ophthalmic SolutionSYd9d71b1d-82a6-42e7-9ef2-2d041daef9364
2702676Oasis Tears PF 0.22 % Ophthalmic SolutionSYd9d71b1d-82a6-42e7-9ef2-2d041daef9364

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
42126-6100-1421266100013 POUCH in 1 CARTON (42126-6100-1) / 10 VIAL, SINGLE-USE in 1 POUCH / .3 mL in 1 VIAL, SINGLE-USE3 pouch2017-11-010000-00-00NoNoCurrent
42126-6100-2421266100025 VIAL, SINGLE-USE in 1 POUCH (42126-6100-2) / .3 mL in 1 VIAL, SINGLE-USE2017-11-010000-00-00NoNoCurrent